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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06466954
Other study ID # P.T.REC/012/003235
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date February 28, 2023

Study information

Verified date June 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study was conducted to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.


Description:

Primary dysmenorrhea (PD) is a common condition characterized by severe menstrual cramps and lower abdominal pain before or during menstruation, without any underlying pelvic pathology. It is highly prevalent among adolescents and young women, with 16% to 93% of adolescents and 70% to 90% of young women experiencing PD. The severe menstrual discomfort associated with PD often leads to absenteeism from school or work, with approximately one-third to half of individuals missing at least one day per menstrual cycle, and 5% to 14% experiencing more frequent absences. While the exact etiology of PD is not fully understood, researchers have proposed a potential relationship between PD and musculoskeletal factors. One hypothesis suggests that abnormal pelvic and lumbar spine alignment, coupled with abdominal muscle spasms, may affect the positioning of the uterus, increasing the susceptibility to dysmenorrhea. Additionally, lumbar spine misalignment could potentially impact uterine blood supply through vasoconstriction, contributing to menstrual pain. Spinal misalignment has been proposed as a possible underlying cause of PD, with some studies suggesting that manual therapy techniques may alleviate PD symptoms. Furthermore, a lack of coordination between the pelvic floor muscles and surrounding soft tissues has also been implicated as a potential causative factor. However, research investigating the relationship between PD and musculoskeletal factors remains limited, and further exploration of the biomechanical factors influencing the pelvic region is needed. Therefore, this study aimed to investigate the correlation between spinopelvic alignment and uterine dimensions in primary dysmenorrhea.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 25 Years
Eligibility Inclusion Criteria: - Virginal and non-smokers. - They should have regular menstrual cycles, verified through a three-month calendar record, with cycle durations averaging between 28 to 35 days. - The body mass index (BMI) varied between 18.5 to 25 kg/m2. - Additionally, girls in the study group should have moderate to severe PD (WaLIDD score = 5). Exclusion Criteria: - Pelvic or gynecological disorders. - Musculoskeletal disorders as low back pain. - Spinal deformities as kyphosis and scoliosis. - History of lower limb injuries. - Diabetes. - Cardiopulmonary diseases. - Any physical impairment. - They didn't use analgesics, non-steroidal anti-inflammatory drugs or oral contraceptives.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluating spinopelvic alignment parameters
Evaluation of thoracic kyphosis, lumbar lordosis, pelvic tilt, and pelvic torsion
Measuring uterine dimensions
Measurement of corpus length, corpus width, cervix length, and cervix width

Locations

Country Name City State
Egypt Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kyphotic angle It was measured by a 4D formetric device as the maximum degree of kyphotic curvature, specifically the angle formed between the upper inflection point adjacent to the vertebral prominence and the thoracic-lumbar inflection point. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Primary Lordotic angle It was measured by a 4D formetric device as the maximum lordotic angle, calculated as the angle formed between the surface tangents at the thoracic-lumbar inflection point and the lower lumbar-sacral inflection point. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Primary Pelvic tilt It was determined by a 4D formetric device as the vertical disparity in millimeters (mm) between the two lumbar dimples. A positive value signifies that the right dimple is positioned higher than the left, while a negative value indicates the reverse, all in relation to a horizontal reference line connecting both dimples within the measuring system. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Primary Pelvic torsion It was measured by a 4D formetric device within the frontal plane, this measurement represents the degree of rotation of the right sacral dimple relative to the left sacral dimple. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Primary corpus length It was measured by ultrasonography. The longitudinal axis of the uterine corpus was determined at a longitudinal plane where the internal cervical os and endometrium appeared at their tallest, measured from the projection point of the endometrium on the uterine corpus to the internal cervical os. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Primary corpus width It was measured by ultrasonography. The transverse axis of the uterine corpus was assessed at the same plane, positioned perpendicular to the longitudinal diameter of the uterine corpus where it exhibited its maximum width. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Primary cervix length It was measured by ultrasonography. t was measured as the distance between the internal cervical os and the external os. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
Primary cervix width It was measured by ultrasonography. The measurement of the transverse diameter of the uterine cervix was conducted at its thickest section, oriented perpendicular to an imaginary line corresponding to the longitudinal measurement of the cervix. It was measured during the 2nd or 3rd days of menstruation for each participant in both groups.
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